Novex Sore Throat: Package Insert and Label Information

NOVEX SORE THROAT- benzocaine and menthol, unspecified form lozenge
Herbion Pakistan (Pvt.) Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients (in each lozenge)

Benzocaine 15 mg

Menthol 3.6 mg

Purposes

Oral pain reliever

Oral pain reliever

Uses
For the temporary relief of occasional

■ sore throat ■ sore mouth ■ minor irritation ■ pain

■ pain associated with canker sores

Methemoglobinemia warning:
Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
■ pale, gray, or blue colored skin (cyanosis)
■ headache
■ rapid heart rate
■ shortness of breath
■ dizziness or lightheadedness
■ fatigue or lack of energy


Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics.


Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

Stop use and ask a doctor or dentist if


■ sore mouth symptoms do not improve in 7 days
■ irritation, pain, or redness persists or worsens
■ swelling, rash, or fever develops


If pregnant or breast-feeding, ask a health professional before use.

Do not use
■ for teething
■ in children under 5 years of age

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Do not exceed recommended dosage

Directions
■ adults and children 5 years of age and older: allow one lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
■ children under 5 years of age: do not use

Other Information:

store at 20-25°C (68-77°F)protect contents from humidity

Inactive Ingredients:

FD&C red no. 40, Flavor, Isomalt, Maltitol, Sodium bicarbonate, Sucralose

Questions?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday 9am — 5pm EST

Novex Sore Throat Cherry

NOVEX SORE THROAT benzocaine and menthol, unspecified form lozenge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44237-045
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 15 mg in 2.5
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 3.6 mg in 2.5
Inactive Ingredients
Ingredient Name Strength
ISOMALT
MALTITOL
SUCRALOSE
SODIUM BICARBONATE
FD&C RED NO. 40
Product Characteristics
Color red Score no score
Shape ROUND Size 17mm
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44237-045-05 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 9 LOZENGE in 1 BLISTER PACK This package is contained within the CARTON (44237-045-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 04/01/2020
Labeler — Herbion Pakistan (Pvt.) Ltd (645482936)
Registrant — Herbion Pakistan (Pvt.) Ltd (645482936)
Establishment
Name Address ID/FEI Operations
Herbion Pakistan (Pvt.) Ltd 645482936 manufacture (44237-045)

Revised: 04/2020 Herbion Pakistan (Pvt.) Ltd

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